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WITHDRAWNPHASE2/PHASE3

Lot Consistency Study of COVID-19 and Influenza Combination Vaccine

A Phase 3, Randomized, Observer-Blinded, Study to Compare the Safety and Immunogenicity of 3 Lots of SARS-CoV-2 rS Nanoparticle and Trivalent Hemagglutinin Nanoparticle Influenza Combination Vaccine With Matrix M™ Adjuvant in Participants ≥ 65 Years of Age

NCT06482359•Novavax

View on ClinicalTrials.gov

Summary

The goal of Phase 3 Study is Comparing the Safety and Immune Response of Three Batches of a COVID-19 and Flu Combination Vaccine in Seniors Aged 65+

Detailed Description

This is a randomized, Phase 3 study comparing the safety and immunogenicity of 3 different lots of Novavax coronavirus disease 2019 (COVID-19) and influenza combination (CIC) vaccine in terms of wild-type influenza hemagglutinin inhibition (HAI) antibody responses to 3 vaccine-homologous influenza strains (i.e., 2 influenza A strains and an influenza B-Victoria lineage strain) and 1 IM dose of Fluzone HD in terms of the neutralizing antibody (NAb) responses to the homologous severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) strain.

Eligibility

Age

65 - 85 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•To be included in this study, each individual must satisfy all the following criteria:
•1. Willing and able to give informed consent prior to study enrollment.
•2. Medically stable adult male or female ≥ 60 years of age at Screening.
•3. Participants may have 1 or more chronic medical diagnoses, but should be clinically stable as assessed by:
•1. Absence of changes in medical therapy in the past 2 months due to treatment failure or toxicity.
•2. Absence of medical events qualifying as SAEs within 3 months; and
•3. Absence of known, current, and life-limiting diagnoses which render survival to completion of the protocol unlikely in the opinion of the Investigator.
•4. The participant has a body mass index (BMI) of 17 to 40 kg/m2, inclusive, at Screening.
•5. Participant must be able to receive an injection in the deltoid of either arm.
•6. Able to attend study visits, comply with study requirements, and provide reliable and complete reports of AEs.
+2 more criteria

Exclusion Criteria

•If an individual meets any of the following criteria, he or she is ineligible for this study:
•1. History of laboratory-confirmed (by polymerase chain reaction \[PCR\] or rapid antigen test) COVID-19 or asymptomatic SARS-CoV-2 infection; either occurring ≤ 8 weeks prior to Screening.
•2. Any ongoing, symptomatic acute illness requiring medical or surgical care or chronic illness that required substantive changes in medication in the past 2 months prior to Screening indicating that chronic illness/disease is not stable (at the discretion of the Investigator). This includes any current workup of undiagnosed illness that could lead to a new condition.
•3. Serious chronic diseases inclusive of:
•1. Uncontrolled hypertension;
•2. Congestive heart failure requiring hospitalization within 3 months prior to Screening;
•3. Chronic obstructive pulmonary disease (COPD) requiring hospitalization within 3 months prior to Screening;
•4. Within 3 months prior to Screening, evidence of unstable coronary artery disease as manifested by cardiac interventions (e.g., cardiac stent placement, coronary artery bypass graft surgery), new cardiac medications for control of symptoms, or unstable angina.
•5. Hospitalization for diabetic ketoacidosis within 6 months prior to Screening
•6. Chronic kidney disease/renal requiring institution of substantive new therapy within 3 months prior to Screening
+18 more criteria

Key Dates

Start Date

February 1, 2025

Primary Completion Date

November 16, 2025

Completion Date

May 17, 2026

Last Updated

March 11, 2025

Conditions

COVID-19Influenza

Interventions

coformulated CIC Vaccine

BIOLOGICAL

Fluzone HD trivalent

BIOLOGICAL

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COVID-19

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RECRUITINGNA

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Post COVID-19 ConditionPost-COVID-19 Syndrome+4 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 11, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Lot Consistency Study of COVID-19 and Influenza Combination Vaccine

Inclusion Criteria

Exclusion Criteria

A Safety and Immunogenicity Trial of Boost-2867 Vaccine, Via Intranasal and Intramuscular Routes

Improving Post COVID-19 Syndrome With Hyperbaric Oxygen Treatments

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